Phenoxodiol trials: focus on ovarian not prostate cancer
Phenoxodiol’s fast track status at FDA generates a lot on interest among men with advanced prostate cancer. But despite evidence that Phenoxodiol delays progression in hormone refractory prostate cancer, is the fast track to FDA approval petering out?
An inquiry this week from a patient in Scandinavia, who is taking chemo for advanced prostate cancer, led us to call Novogen, where a spokesman said that although phenoxodiol is still fast tracked for prostate cancer, the company is concentrating its resources on a clinical trial for ovarian cancer. Phenoxodiol is being tested for women with advanced ovarian cancer as chemo sensitizer along with carboplatin, This is the OVATURE (OVArian TUmor REsponse) Study, official Title: Multi-Center, Randomized, Double-Blind, Phase III Efficacy Study Comparing Phenoxodiol in Combination With Carboplatin Versus Carboplatin With Placebo in Patients With Platinum-Resistant or Platinum-Refractory Late-Stage Epithelial Ovarian, Fallopian or Primary Peritoneal Cancer Following at Least Second Line Platinum Therapy.” The study begins this month and is expected to recruit 470 patients.
Given the realities of clinical trials, a Novogen spokesman told us today, the company believes that by focusing their attention on this ovarian cancer Phase III trial they are following “the shortest route” to FDA approval of phenoxodiol.
You mention Flurbiprofen (Ansaid). This is a NSAID (nonsteroidal anti-inflammatory), a different class of drug from phenoxodiol. Yes, clinical trials to see whether NSAIDs slow prostate cancer progression and recurrence are ongoing, with some promising results, and some medical oncologists already prescribe these drugs.
I want to mention that Prof James Morre, who showed that Phenoxodiol slows cancer growth by inhibiting a tNOX pathway (tNOX 75 alpha), has produced a combination of (decaffeinated) green tea and capsicum (hot pepper) which he claims does similarly. For his lab’s finding on tNOX and Phenoxodiol see:
http://www.medicalnewstoday.com/medicalnews.php?newsid=52029
And for Capsol-T, which appears to be available for purchase and might be worth a shot:
http://www.capsol-t.com/howitworks.htm
About hot peppers and PCa:
http://www.psa-rising.com/eatingwell/peppers_hot.htm
Side effects for Flurbiprofen are listed by University of Maryland:
http://www.umm.edu/altmed/ConsDrugs/Flurbiprofencd.html
You also might be interested in these articles:
Vitamin D, NSAIDS provide double whammy against prostate cancer, Stanford study
http://www.psa-rising.com/med/chemo/vitD_NSAIDs05.html
Use of aspirin or other NSAIDs increases survival for men with prostate cancer
http://www.psa-rising.com/med/prevention/NSAIDS_protect1004.htm
An index of our earlier coverage of NSAIDs and PCa:
Comment by admin — October 21, 2006 @ 5:18 pmhttp://psa-rising.com/med/recurrent/nsaid.htm
i too called nuvogen and talked extensively to the rep there…and this is what he told me…
phenoxidiol not only received a fast track designation from the FDA, but yet another designation of which i can’t for the life of me remember the name…
however, it is this secondary designation which will take phenoxidiol directly to market for prostate cancer.
so be patient…i know it’s hard…but, it will happen. just make sure your doctor is familiar with its properties…as i find most doctors are not even aware of its existence.
i am not a doctor, but the wife of a veteran who has a gleason 10 complicated by his exposure to agent orange…he’s managed to keep his numbers down low now for 16 months post radiation…with diet, exercise, and a box full of supplements 4 times a day….the kicker, i believe is fermented soy genistein. he takes over 800 mg. of soy genistein per day…and i buy it from life extension discounted through http://www.betterlife.com. when he rebelled and stopped taking them his psa climbed and when he resumed, it went right back down. i don’t believe this was a post radiation ”bump” as it’s referred to because he rebels a lot and the psa goes up and down with rebellion and resumption. so, i’m pretty sure that any drug that tweaks genistein may be something to wait for…
in my research, i also found a reference to
Comment by fleas — October 19, 2006 @ 7:14 pmFLURBIPROPHEN, TRADE NAME ANSAID…an anti-inflammatory drug. seems a dutch researcher
inadvertently discovered that flurbiprophen interrupts some very necessary signalling pathways for PCa cells. as i accessed clinical trails the other day i noticed there are extensive clinical trials being recruited and conducted on flurbiprophen for PCa. Nothing as innocuous as an aspirin can do any harm for most sufferers (just be careful if you have a sensitive stomach or take blood thinners)so i purchase it from medsmex.com, as the VA will only prescribe proven remedies…not even avodart. i wish i could find a way to order IT online…anything to keep him in good shape until phenoxodiol is approved.
I am glad that Jacquie has obtained information on the status of this medication. I wrote to the manufacturer on August 29 regarding its status as to PCa and was not granted the courtesy of a reply.
This does not look as if we PCa patients can expect results as to our disease any time within the next several years.
If phenoxodiol (PXD) is approved for ovarian cancer, a terrible disease, that is fine but will mean little to others.
However: it occurs to me that Proscar and Avodart are approved for tx of BPH, but not for suppression of formation of dihydrotestosterone (DHT). But they are sometimes used “off-label” to do exactly that. I am an example.
So the question occurs: if PXD is approved for ovarian cancer and is thus on the market, might advanced PCa patients see an off-label benefit from its use in their chemotherapy? Hmmm. I hope I don’t have to depend upon this for my survival, but it’s an interesting thought.
Regards,
Steve J
Comment by mycroft — October 15, 2006 @ 12:35 am